Cleared Traditional

K231865 - Mouth Guard (ATG0603R) (FDA 510(k) Clearance)

K231865 · Reazeal Corp · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2023
Decision
133d
Days
-
Risk

K231865 is an FDA 510(k) clearance for the Mouth Guard (ATG0603R). Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Reazeal Corp (Wilmington, US). The FDA issued a Cleared decision on November 6, 2023 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Reazeal Corp devices

Submission Details

510(k) Number K231865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2023
Decision Date November 06, 2023
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 127d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Consultant

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 44
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K231865.
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K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 2024